Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT02470234
Status:
COMPLETED
Last Update Posted:
2021-11-24
First Post:
2015-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetic Study of Methylphenidate HCl Extended-Release Capsules in Children 4 to Under 6 Years of Age With ADHD
Sponsor:
Organization:
Raw JSON
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Methylphenidate HCl ER 10 mg', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Methylphenidate HCl ER 15 mg', 'description': 'Subjects received a single dose of Methylphenidate HCl ER 15 mg', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Methylphenidate HCl ER 20 mg', 'description': 'Subjects received a single dose of Methylphenidate HCl ER 20 mg', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'notes': 'Not Related to study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylphenidate HCl ER 10 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions'}, {'id': 'OG001', 'title': 'Methylphenidate HCl ER 15 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions'}, {'id': 'OG002', 'title': 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'groups': [{'id': 'OG000', 'title': 'Methylphenidate HCl ER 10 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}, {'id': 'OG001', 'title': 'Methylphenidate HCl ER 15 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}, {'id': 'OG002', 'title': 'Methylphenidate HCl ER 20 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 20 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.18', 'spread': '25.047', 'groupId': 'OG000'}, {'value': '118.49', 'spread': '18.211', 'groupId': 'OG001'}, {'value': '155.95', 'spread': '35.209', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Area under the plasma concentration versus time curve (calculated to the last measurable observation).\n\nAUC: Area Under the Curve', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol'}, {'type': 'PRIMARY', 'title': 'AUC(0-inf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylphenidate HCl ER 10 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}, {'id': 'OG001', 'title': 'Methylphenidate HCl ER 15 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}, {'id': 'OG002', 'title': 'Methylphenidate HCl ER 20 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 20 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '105.26', 'spread': '21.831', 'groupId': 'OG000'}, {'value': '140.68', 'spread': '0', 'groupId': 'OG001'}, {'value': '144.26', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Area under the plasma concentration versus time curve, extrapolated to infinity.\n\nAUC: Area Under the Curve', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol. (n=1) Standard Deviation was not estimable.'}, {'type': 'PRIMARY', 'title': 'AUC/D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylphenidate HCl ER 10 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}, {'id': 'OG001', 'title': 'Methylphenidate HCl ER 15 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}, {'id': 'OG002', 'title': 'Methylphenidate HCl ER 20 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 20 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.92', 'spread': '2.505', 'groupId': 'OG000'}, {'value': '7.90', 'spread': '1.214', 'groupId': 'OG001'}, {'value': '7.80', 'spread': '1.760', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Dose-normalized AUC0-t. AUC: Area Under the Curve', 'unitOfMeasure': 'ng*hr/mL/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol.'}, {'type': 'PRIMARY', 'title': 'CL/F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylphenidate HCl ER 10 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}, {'id': 'OG001', 'title': 'Methylphenidate HCl ER 15 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}, {'id': 'OG002', 'title': 'Methylphenidate HCl ER 20 mg Capsule', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 20 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.51', 'spread': '18.095', 'groupId': 'OG000'}, {'value': '106.63', 'spread': '0', 'groupId': 'OG001'}, {'value': '138.64', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Apparent clearance. CL: Clearance', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol. (n=1) Standard Deviation was not estimable.'}, {'type': 'PRIMARY', 'title': 'V(Dss)/F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylphenidate HCl ER 10 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}, {'id': 'OG001', 'title': 'Methylphenidate HCl ER 15 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}, {'id': 'OG002', 'title': 'Methylphenidate HCl ER 20 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 20 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '682.49', 'spread': '182.605', 'groupId': 'OG000'}, {'value': '1952.17', 'spread': '0', 'groupId': 'OG001'}, {'value': '1396.96', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Volume of distribution', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol. (n=1) Standard Deviation was not estimable.'}, {'type': 'PRIMARY', 'title': 'Cmax/Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylphenidate HCl ER 10 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}, {'id': 'OG001', 'title': 'Methylphenidate HCl ER 15 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}, {'id': 'OG002', 'title': 'Methylphenidate HCl ER 20 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 20 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.81', 'spread': '0.170', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.041', 'groupId': 'OG001'}, {'value': '0.77', 'spread': '0.053', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Dose-normalized Cmax', 'unitOfMeasure': 'ng/mL/mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol'}, {'type': 'SECONDARY', 'title': 'Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylphenidate HCl ER 10 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.\n\n.'}, {'id': 'OG001', 'title': 'Methylphenidate HCl ER 15 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}, {'id': 'OG002', 'title': 'Methylphenidate HCl ER 20 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 20 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '12.0'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Time to peak plasma concentration', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol'}, {'type': 'SECONDARY', 'title': 'T1/2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylphenidate HCl ER 10 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}, {'id': 'OG001', 'title': 'Methylphenidate HCl ER 15 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}, {'id': 'OG002', 'title': 'Methylphenidate HCl ER 20 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 20 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.80', 'spread': '0.466', 'groupId': 'OG000'}, {'value': '12.69', 'spread': '0', 'groupId': 'OG001'}, {'value': '6.98', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Elimination half-life', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol. (n=1) Standard Deviation was not estimable.'}, {'type': 'SECONDARY', 'title': 'Kel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Methylphenidate HCl ER 10 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 10 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}, {'id': 'OG001', 'title': 'Methylphenidate HCl ER 15 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 15 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}, {'id': 'OG002', 'title': 'Methylphenidate HCl ER 20 mg', 'description': 'Active drug, administered once\n\nMethylphenidate HCl ER 20 mg Capsule: Methylphenidate Hydrochloride Extended-Release Capsules single dose administered in the morning under fed conditions.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.15', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0', 'groupId': 'OG001'}, {'value': '0.10', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Terminal elimination constant', 'unitOfMeasure': 'h-1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol. (n=1) Standard Deviation was not estimable'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Methylphenidate HCl ER 10 mg', 'description': 'Subjects received a single dose of Methylphenidate HCl ER 10 mg . This dose was equivalent to their current total daily methylphenidate dose.'}, {'id': 'FG001', 'title': 'Methylphenidate HCl ER 15 mg', 'description': 'Subjects received a single dose of Methylphenidate HCl ER 15 mg . This dose was equivalent to their current total daily methylphenidate dose.'}, {'id': 'FG002', 'title': 'Methylphenidate HCl ER 20 mg', 'description': 'Subjects received a single dose of Methylphenidate HCl ER 20 mg . This dose was equivalent to their current total daily methylphenidate dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'It was a parallel design study, where subjects were recruited from July 02, 2016 - July 19, 2017. Eligible subjects received one capsule of Methylphenidate HCl ER (10, 15, 20, 30, or 40 mg) on only one of the 3 dosing days depending on number of subjects recruited up each particular dosing day. Only 1 site was able to recruit subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Methylphenidate HCl ER 10 mg', 'description': 'Subjects received a single dose of Methylphenidate HCl ER 10 mg'}, {'id': 'BG001', 'title': 'Methylphenidate HCl ER 15 mg', 'description': 'Subjects received a single dose of Methylphenidate HCl ER 15 mg'}, {'id': 'BG002', 'title': 'Methylphenidate HCl ER 20 mg', 'description': 'Subjects received a single dose of Methylphenidate HCl ER 20 mg'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'spread': '8.03', 'groupId': 'BG000'}, {'value': '63.3', 'spread': '5.51', 'groupId': 'BG001'}, {'value': '70.5', 'spread': '0.71', 'groupId': 'BG002'}, {'value': '63.6', 'spread': '7.06', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'spread': '0.55', 'groupId': 'BG000'}, {'value': '15.3', 'spread': '0.98', 'groupId': 'BG001'}, {'value': '15.3', 'spread': '2.26', 'groupId': 'BG002'}, {'value': '15.3', 'spread': '0.96', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-13', 'size': 1128688, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-21T15:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open-label, single-dose'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-27', 'studyFirstSubmitDate': '2015-06-03', 'resultsFirstSubmitDate': '2020-09-21', 'studyFirstSubmitQcDate': '2015-06-11', 'lastUpdatePostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-27', 'studyFirstPostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Maximum plasma concentration'}, {'measure': 'AUC(0-t)', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Area under the plasma concentration versus time curve (calculated to the last measurable observation).\n\nAUC: Area Under the Curve'}, {'measure': 'AUC(0-inf)', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Area under the plasma concentration versus time curve, extrapolated to infinity.\n\nAUC: Area Under the Curve'}, {'measure': 'AUC/D', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Dose-normalized AUC0-t. AUC: Area Under the Curve'}, {'measure': 'CL/F', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Apparent clearance. CL: Clearance'}, {'measure': 'V(Dss)/F', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Volume of distribution'}, {'measure': 'Cmax/Dose', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Dose-normalized Cmax'}], 'secondaryOutcomes': [{'measure': 'Tmax', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Time to peak plasma concentration'}, {'measure': 'T1/2', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Elimination half-life'}, {'measure': 'Kel', 'timeFrame': 'Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose', 'description': 'Terminal elimination constant'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ADHD', 'Children', 'Pharmacokinetics'], 'conditions': ['Attention-Deficit/Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '32776159', 'type': 'DERIVED', 'citation': 'Adjei AL, Chaudhary I, Kollins SH, Padilla A. A Pharmacokinetic Study of Methylphenidate Hydrochloride Multilayer Extended-Release Capsules (Aptensio XR(R)) in Preschool-Aged Children with Attention-Deficit/Hyperactivity Disorder. Paediatr Drugs. 2020 Oct;22(5):561-570. doi: 10.1007/s40272-020-00409-z.'}]}, 'descriptionModule': {'briefSummary': 'To assess the pharmacokinetics of a single dose of Aptensio XR® (methylphenidate hydrochloride extended-release) capsules under fed conditions in male or female children 4 to under 6 years of age with ADHD.', 'detailedDescription': 'This will be a multi-center, open-label, single-dose, study to assess the pharmacokinetics of Aptensio XR® (methylphenidate hydrochloride extended-release) capsules in male and female children 4 to under 6 years of age with ADHD in fed condition.\n\nScreening Procedures: After obtaining written informed consent from parents, subjects will undergo a complete medical and medication history, demographic data (including sex, age, race, ethnicity, body weight (kg), height (cm), Body Mass Index (BMI) (kg/m2), physical examination, vital signs evaluation (sitting blood pressure, pulse rate, respiration rate, temperature and pulse oximetry), resting 12-lead electrocardiogram (ECG), clinical laboratory tests and concomitant medication within 28 days prior to receiving study drug. On Day 1: subjects will receive a single oral dose of Aptensio XR®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient is a male or female between the ages of 4 and under 6 years old.\n2. Patient has a history consistent with ADHD, meets the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for ADHD, inattentive, hyperactivity or combined.\n3. Patient must meet criteria for ADHD diagnosis on Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime (KSADS-PL) and clinical interview by experienced clinician; symptoms must have been present for at least 6 months.\n4. Subject has had prior behavioral treatment or subject's symptoms are severe enough to warrant treatment without prior behavioral treatment, and patient is on a stable dose of either immediate-release or extended-release methylphenidate.\n5. Subject must have age- and sex-adjusted ratings of ≥ 90th percentile Total Score on the Attention Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) Preschool Version, a Clinical Global Impressions -Severity Score of ≥4 and a Child Global Assessment Scale rating of \\<65 after methylphenidate washout and prior to obtaining pharmacokinetic samples. Ratings may be completed via telephone on day-1.\n6. Parents or guardians of patients must have the ability to read and understand the language in which the Informed Consent is written and are mentally and physically competent to provide written informed consents for their child.\n7. Patient and/or parent are/is able to understand English in order to provide assent and is otherwise able to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Patient has allergy to methylphenidate or amphetamines, or history of serious adverse reaction to methylphenidate.\n2. Patient has a history of tension, agitation, glaucoma, thyrotoxicosis, tachyarrhythmias or severe angina pectoris or patient with serious or unstable medical illness such as asthma, diabetes or seizures.\n3. A history of motor or vocal tics or Tourette's syndrome\n4. Patient is receiving monoamine oxidase inhibitors, anticonvulsants (phenobarbital, phenytoin, primidone), coumarin anticoagulants, presser agents, guanethidine, tricyclic antidepressants (imipramine, desipramine, selective serotonin inhibitors (SSRIs), or herbal remedies (e.g., melatonin).\n5. Patient has serious hypertension.\n6. Patient has a history of disorders of the sensory organs, particularly deafness, severe or profound retardation.\n7. Patient has any other unstable psychiatric condition requiring treatment.\n8. Patient is at risk for substance abuse.\n9. Evidence of current physical, sexual, or emotional abuse\n10. Living with anyone who currently abuses stimulants or cocaine\n11. History of bipolar disorder in both biological parents"}, 'identificationModule': {'nctId': 'NCT02470234', 'acronym': 'PK003', 'briefTitle': 'Pharmacokinetic Study of Methylphenidate HCl Extended-Release Capsules in Children 4 to Under 6 Years of Age With ADHD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rhodes Pharmaceuticals, L.P.'}, 'officialTitle': 'A Pharmacokinetic Study of Aptensio XR® (Methylphenidate Hydrochloride (HCl) Extended-release) Capsules in Male or Female Pre-School Children 4 to Under 6 Years of Age With Attention Deficit Hyperactivity Disorder (ADHD) in Fed Condition', 'orgStudyIdInfo': {'id': 'RP-BP-PK003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methylphenidate HCl ER Capsules, 10 mg', 'description': 'Methylphenidate Hydrochloride Extended Release Capsules, 10 mg. Active drug, administered once', 'interventionNames': ['Drug: Methylphenidate HCl ER Capsules, 10 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Methylphenidate HCl ER Capsules, 15 mg', 'description': 'Methylphenidate Hydrochloride Extended Release Capsules, 15 mg. Active drug, administered once', 'interventionNames': ['Drug: Methylphenidate HCl ER Capsules, 15 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Methylphenidate HCl ER Capsules, 20 mg', 'description': 'Methylphenidate Hydrochloride Extended Release Capsules, 20 mg. Active drug, administered once', 'interventionNames': ['Drug: Methylphenidate HCl ER Capsules, 20 mg']}], 'interventions': [{'name': 'Methylphenidate HCl ER Capsules, 10 mg', 'type': 'DRUG', 'otherNames': ['Aptensio XR®, 10 mg'], 'description': 'Methylphenidate Hydrochloride Extended-Release Capsules, 10 mg administered once daily in the morning', 'armGroupLabels': ['Methylphenidate HCl ER Capsules, 10 mg']}, {'name': 'Methylphenidate HCl ER Capsules, 15 mg', 'type': 'DRUG', 'otherNames': ['Aptensio XR®, 15 mg'], 'description': 'Methylphenidate Hydrochloride Extended-Release Capsules, 15 mg administered once daily in the morning', 'armGroupLabels': ['Methylphenidate HCl ER Capsules, 15 mg']}, {'name': 'Methylphenidate HCl ER Capsules, 20 mg', 'type': 'DRUG', 'otherNames': ['Aptensio XR®, 20 mg'], 'description': 'Methylphenidate Hydrochloride Extended-Release Capsules, 20 mg administered once daily in the morning', 'armGroupLabels': ['Methylphenidate HCl ER Capsules, 20 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Qps-Mra, Llc', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Psychiatry and Behavioral Sciences, Duke University School of Medicine', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Akwete Adjei, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rhodes Pharmaceuticals, L.P.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhodes Pharmaceuticals, L.P.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}